Device Classification Name |
counter, differential cell
|
510(k) Number |
K955715 |
Device Name |
CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) |
Applicant |
ABBOTT LABORATORIES |
5440 PATRICK HENRY DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
JANICE E BROWN |
Correspondent |
ABBOTT LABORATORIES |
5440 PATRICK HENRY DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
JANICE E BROWN |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 11/30/1995 |
Decision Date | 10/08/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|